The word 'critical" has three meanings which are dangerous, important, and disapproving. The purpose of this blog is to examine important or over-looked cultural, political, artistic, or historical issues of our time. Also, this blog is intended to be educational.

Tuesday, June 27, 2017

The Hidden Dangers of Makeup and Shampoo

There's more to your makeup than meets the
eye. New research shows that health-related complaints about cosmetic products like shampoo and makeup are at an
all-time high since the U.S. Food and Drug Administration (FDA) began keeping
track more than a decade ago.

That's concerning, because when cosmetic
products cause health issues, addressing the problem or even getting a
potentially unsafe product off the market—isn't a simple process. Currently,
cosmetic manufacturers have no legal obligation to report health problems from
their products to the FDA. Cosmetics also do not need to go through a
pre-market approval process before they are sold in stores, and regulators do
not assess the safety and effectiveness of the claims on the products. Instead,
people and doctors are asked to report any health complications to the FDA's
database (called the Center for Food Safety and Applied
Nutrition’s Adverse Event Reporting System, or CFSAN). If the FDA sees any increases
that warrant concern, they can investigate.

"As a dermatologist, we live and breathe
cosmetics and personal care products," says study author Dr. Steve Xu, a
resident physician in the department of dermatology at Northwestern University
Feinberg School of Medicine, citing his motivation for the study. "I get
asked every day, 'What is safe to use?'"

In the new research letter, Xu and his colleagues
looked at the number of adverse events reported to the FDA and found that over
a 12-year period, there were 5,144 health-related complaints submitted due
to cosmetic products.

The
study authors were able to evaluate the number of cases reported to the agency
because in 2016, the FDA made the CFSAN database publicly available. The new
researched shows that between 2004 and 2016, an average of 396 events were
reported per year, with an increase between 2015 to 2016. The three most
commonly cited products were for hair care, skin care and tattoos. "This
isn't designed to be alarmist," says Xu. Still, "we have this huge
industry and there are lots of chemicals in these products that largely go
unregulated."

After and Before

Relying
on self-reported cases means there's a lot of under reporting, and it can be
tough to definitively determine whether a given item is causing harm - even when
there's a spike in complaints. In 2014, for example, the FDA started toinvestigate
WEN by Chaz Dean Cleansing Conditionerswhen
the product received 127 complaints from users that it was causing their hair
to fall out, among other problems. When the FDA reached out to the company,
they discovered that the manufacturer had received 21,000 complaints related to
hair loss and scalp problems. However, as of now, the product remains on the
market.

In acorresponding
editorial, three experts - including the most recent
former commissioner of the FDA, Dr. Robert M. Califf - say that the challenge
of overseeing cosmetic safety is "daunting" for regulators. The
global cosmetics industry is expected to reach $265 billion in revenue in 2017,
yet, the FDA's Office of Cosmetics and Colors has a budget of about $13 million
for 2017. "For products that are used routinely, small effects over time
within large populations can be almost impossible to detect without active
surveillance," they write. "Even when health risks are substantial,
as with tobacco products, the path to identifying and interpreting those safety
signals clearly enough to justify regulatory action is often long and
tortuous."

To
combat the problem, the writers of both the study and the editorial argue that
better surveillance is needed. Xu encourages more people and their doctors to
provide thorough reports to the FDA, and he argues companies should take a
greater role in this reporting, too. "I think broader reporting from all
parties and mandatory reporting from manufacturers is not a controversial thing
to ask for," says Xu. Increasing the agency's budget and oversight is
another solution, and the editorial authors argue the agency is "under resourced
for even the very limited responsibilities it currently has for the safety of
cosmetics." However, a bump to the FDA's budget, at least for now, doesn't
seem likely, as the agency is facing the potential forbudget cutsin
the near future.